The Association of Bariatric Medical Specialist (ABIM) is challenging the validity of the Accreditation Commission for Health Informatics and Information Management (ACIIM) for approving the ABIM’s current certification process. According to the Association of Bariatric Medical Specialist, the ABIM is guilty of “dubious and self-serving” practices such as excluding women from training courses and denying malpractice claims on the basis of pre-existing conditions. ACIIM, the association contends, has created a double standard for health care providers by failing to apply the rules to itself. For this reason, it has filed suit against the ABIM and against the other two major accrediting bodies, the American Board of Medical Specialties (ABMS) and the American Association of Clinical Endocrinologists (AACER).
Currently, ABIM offers two types of certification: Professional/Certified Medical Assistant (PCMA) and Certified Professional Respiratory Diagnostic Medical Assistant (CPRM). The PCMA is designed for one specialized field of medicine, and the CPRM is designed for two specialized fields of medicine. Currently, the ACM is attempting to distinguish itself from ABIM in terms of its application to professional/certified nurses and physicians. The Association of Bariatric Medical Specialist argues that the Philadelphia based ABIM fails to meet the requirement of the federal government’s definition of a criminal enterprise engaged in racketeer activity, pointing out the many intertwined threads tying the industry, including the manufacturers’ efforts to influence doctors and nurses through special interest groups and directly linking physicians and nurses to the federal government’s Medicare reimbursement program, known as Medigap. The ACM also contends that ABIM is guilty of excluding qualified women from training courses on the basis of gender, which violates the requirement of the landmark Act. Additionally, the ACM claims that it has been forced to drop its certification due to the lawsuits, and has had to pay over seven million dollars to settle the lawsuits.
There are two main issues at play here. First, the original certification was not intended to exclude surgeons and other medical staff, but rather required that all companies manufacturing products that benefit the healthcare system to document that they have provided proof of an ABIM certification, including documentation of internal, independent audits and third party independent studies. Second, plaintiffs argue that the current version of the ABIM certification, which is available for all companies involved in the lawsuit, does not meet this requirement and therefore violates the civil rights of current and former plaintiffs. Both sides have strong points, and the outcome of the Philadelphia lawsuit could be significantly influenced by these arguments.
The primary issue currently before the Philadelphia lawsuit is whether ABIM has violated its duty of care to provide notice that its manufacturers have met all of their mandatory pre-certification requirements, as outlined in the landmark Act. The Philadelphia lawsuit is seeking damages on a claim that ABIM has refused to provide evidence of independent internal audits and third party studies showing that its products to prevent or reduce the risk of breast cancer, or demonstrate that it has provided safe product performance data. As we’ve seen, the FDA has long interpreted the phrase “safe” in a way that requires courts to take the manufacturers at their word when they say that their product is safe under the conditions that they set forth in the labeling. That’s led to decades-worth of lawsuits, and one very important issue that will always remain: Is the FDA’s definition of safe a reasonable one? ABA is certainly not settled, and attorneys involved in these lawsuits feel that the FDA’s current definition is too strict.
One way that attorneys are arguing against ABIM is that they have not been properly reviewed. Philadelphia lawsuit co-counseling expert Vincent Sheehan says that there was one case in which ABIM failed to meet their maintenance certification deadlines, despite meeting all of their other mandatory deadlines. Also, a case in which ABIM was granted a maintenance certification, but then was unable to produce enough documents to support it was subsequently thrown out because the company was unable to produce the said documentation. If these companies truly want to be deemed safe, as is claimed by many in the industry, then the requirements of ABIM need to change.
Another argument that some attorneys have made in opposition to ABIM is that the amended complaint improperly allows some physicians to bill patients for insurance payments from ABIM even though they never received any actual ABIM direct payments. This would allow doctors to bill for services that weren’t received, and therefore violate the regulations set forth by the ABIM. The plaintiffs argue that plaintiffs have a legitimate claim that the ABIM has failed to provide a reasonable accommodation to their needs. The amended complaint does not alter the definition of ABIM itself, nor does it alter the fact that it is required by law to provide insurance payments for services that were actually received.